APPLICATION
NDA019487
TYPE
NDA
ORIGINAL APPROVAL
1988-03-01
LATEST ACTION
2019-08-07
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued, Over-the-counter
Products
IMODIUM A-D · ReferenceDiscontinued
LOPERAMIDE HYDROCHLORIDE 1MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · ORAL
IMODIUM A-D · ReferenceOver-the-counter
LOPERAMIDE HYDROCHLORIDE 1MG/7.5ML · SOLUTION · ORAL
Approval history
2017-04-12Labeling · Supplement 30 · standardAP
2016-05-17Manufacturing (CMC) · Supplement 29 · standardAP
1999-12-03Manufacturing (CMC) · Supplement 18 · standardAP
1998-09-04Manufacturing (CMC) · Supplement 16 · standardAP
1996-10-28Labeling · Supplement 15 · standardAP
1996-03-22Labeling · Supplement 14 · standardAP
1996-02-12Manufacturing (CMC) · Supplement 13 · standardAP
1994-08-15Labeling · Supplement 12 · standardAP
1993-05-13Manufacturing (CMC) · Supplement 8 · standardAP
1992-11-23Efficacy · Supplement 7AP
1992-07-16Manufacturing (CMC) · Supplement 11 · standardAP
1991-05-17Manufacturing (CMC) · Supplement 9 · standardAP
1990-02-09Manufacturing (CMC) · Supplement 6 · standardAP
1990-01-29Manufacturing (CMC) · Supplement 5 · standardAP
1989-01-05Manufacturing (CMC) · Supplement 4 · standardAP
1988-12-06Manufacturing (CMC) · Supplement 1 · standardAP
1988-03-01Type 5 - New Formulation or New Manufacturer · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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